BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR SMOOTH ROUND HIGH PROFILE

    MDR report key: 17748617 · Received September 14, 2023

    Report

    Report Number
    1645337-2023-10551
    Event Type
    Injury
    Date Received
    September 14, 2023
    Date of Event
    July 19, 2019
    Manufacturer
    MENTOR TEXAS
    Product Code
    FWM
    UDI-DI
    00081317001645
    PMA / PMN Number
    P990075
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    SINCE THE DEVICE HAS NOT BEEN RETURNED FOR ANALYSIS, NO PRODUCT FAILURE ANALYSIS CAN BE CONDUCTED, AND NO DETERMINATION OF POSSIBLE CONTRIBUTING FACTORS CAN BE MADE. AS SUCH, THE INVESTIGATION WILL BE CLOSED. IF THE COMPLAINT DEVICE IS RECEIVED IN THE FUTURE, THE INVESTIGATION WILL BE REOPENED AND CONDUCTED AS APPROPRIATE. A MANUFACTURING RECORD EVALUATION (MRE) WAS PERFORMED, AND NO ANOMALIES WERE FOUND RELATED TO THIS COMPLAINT. IN ADDITION, THE MRE VERIFIES THAT THE DEVICE WAS MANUFACTURED IN ACCORDANCE WITH DOCUMENTED SPECIFICATION AND PROCEDURES. REASON FOR DEVICE EXPLANT AND/OR REOPERATION: LEFT BREAST MASS. MENTOR IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH MENTOR HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, MENTOR, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, MENTOR, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 0

    ON (B)(6) 2023, DEVICE RE-EVALUATION WAS RE-EVALUATED. DEVICE RE-EVALUATION SUMMARY: MENTOR CONDUCTED A VISUAL INSPECTION OF THE RETURNED DEVICE. DURING THE VISUAL EVALUATION, NO APPARENT DAMAGE OR VISUAL ANOMALIES WERE OBSERVED ON THE SM HPS DV 330CC RETURNED DEVICE. SOME BREAST PTOSIS IS A NORMAL COMPONENT OF THE MATURE BREAST. PTOSIS BECOMES UNDESIRABLE WHEN THE BREAST PARENCHYMA PREDOMINATES BELOW THE AREOLA, DROOPS CONSIDERABLY BELOW THE INFRAMAMMARY FOLD AND THE NIPPLE POINTS DOWNWARD. AUGMENTATION ALONE, WITHOUT CONSIDERATION OF THE PTOSIS, CAN PRODUCE A LESS THAN DESIRABLE COSMETIC RESULT KNOWN AS A "ROCK IN SOCK" DEFORMITY OR AN INCREASED PTOTIC APPEARANCE. PTOSIS IS A KNOWN COMPLICATION ASSOCIATED WITH THESE DEVICES AND IS REFERENCED IN OUR CURRENT PRODUCT INSERT DATA SHEET. IT SHOULD BE NOTED THAT AS PART OF MENTOR¿S QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. SINCE NO MALFUNCTION WAS OBSERVED DURING THE INVESTIGATION, CAPA ACTIVITY WAS NOT REQUIRED.  ADDITIONAL COMPLAINT INFORMATION MONITORING FOR POTENTIAL SAFETY SIGNALS IS CONDUCTED THROUGH COMPLAINT TRENDING AS PART OF POST-MARKET SURVEILLANCE. THIS SUPPLEMENTAL MEDWATCH REPORT IS FOR THE PATIENT¿S LEFT-SIDED DEVICE. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 0

    PER ADDITIONAL INFORMATION RECEIVED ON SEPTEMBER 25, 2023, AND REVIEWED BY THE CLINICIAN, FOLLOWING UPDATES HAVE BEEN MADE ON THIS FORM: - PROCEDURE PERFORMED WAS BREAST RECONSTRUCTION - HEALTH EFFECT - IMPACT CODE "SURGICAL INTERVENTION" HAS BEEN ADDED TO FIELD H6 PER THE BIOPSIES MENTIONED UNDER OPERATIVE REPORT. - CLINICAL CODE "DEFORMITY/ DISFIGUREMENT" HAS ALSO BEEN ADDED TO H6 PER MEDICAL NOTES THAT THE PATIENT ALSO EXPERIENCED BILATERAL PTOSIS - CLINICAL CODE BREAST MASS HAS BEEN REMOVED AND "BREAST CANCER RECURRENCE" HAS BEEN ADDED PER CLINICIAN'S REVIEW THIS SUPPLEMENTAL MEDWATCH REPORT IS FOR THE PATIENT¿S LEFT-SIDED DEVICE. RIGHT SIDE PTOSIS IS BEING REPORTED SEPARATELY. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 0

    ON SEPTEMBER 25, 2023, THE MENTOR FAILURE ANALYSIS LAB RECEIVED THE DEVICE FOR EVALUATION, AND DEVICE EVALUATION WAS COMPLETED. DEVICE EVALUATION SUMMARY: MENTOR CONDUCTED A VISUAL INSPECTION OF THE RETURNED DEVICE. DURING THE VISUAL EVALUATION, NO APPARENT DAMAGE OR VISUAL ANOMALIES WERE OBSERVED ON THE SM HPS DV 330CC RETURNED DEVICE. IT SHOULD BE NOTED THAT AS PART OF MENTOR¿S QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. SINCE NO MALFUNCTION WAS OBSERVED DURING THE INVESTIGATION, CAPA ACTIVITY WAS NOT REQUIRED.  ADDITIONAL COMPLAINT INFORMATION MONITORING FOR POTENTIAL SAFETY SIGNALS IS CONDUCTED THROUGH COMPLAINT TRENDING AS PART OF POST-MARKET SURVEILLANCE. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A 49-YEAR-OLD HISPANIC FEMALE PATIENT UNDERWENT BREAST SURGERY WITH A 330CC MENTOR SMOOTH ROUND HIGH PROFILE AND EXPERIENCED BREAST MASS ON HER LEFT SIDE POSTOPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT REMOVAL ONLY SURGERY ON (B)(6) 2022. MENTOR IS AWARE THAT THE DATE OF IMPLANT (B)(6) 2006 IS PRIOR TO THE MANUFACTURING DATE (OCTOBER 20, 2007) OF REPORTED LOT NUMBER 5780584. MULTIPLE FOLLOW UPS WERE COMPLETED FOR CLARIFICATION. HOWEVER, NO RESPONSE WAS RECEIVED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, IT WILL BE UPDATED AND SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    357400 MENTOR SMOOTH ROUND HIGH PROFILE PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FWM MENTOR TEXAS 5780584 00081317001645

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Female Required Intervention| L